Experienced and flexible, Tox Clarity supports your team at any scale – from providing a discrete second opinion to leading a comprehensive nonclinical program.

Tox Clarity advances the nonclinical development of your drug in four arenas.

  • Strategy

    Build road maps for the nonclinical development of new drug products

    • Enable first-in-man clinical studies through marketing authorization
      • Optimize opportunities for streamlined programs and study waivers
      • Coordinate multi-year scientific programs to support go/ no-go business decisions
    • Characterize small molecules and biologics
      • Niche expertise in dermatologic, ophthalmic, and hematologic indications
    • Develop realistic timelines and budgets
  • Empirical Study

    Design scientific assessments to meet regulatory objectives

    • Enable INDs and NDAs/BLAs with toxicology studies conducted in accordance with FDA and ICH Guidances, Good Laboratory Practices, and industry standards
    • Address clinical hold concerns
    • Meet post-marketing committments

    Manage wet-lab experiments at external toxicology laboratories

    • Guide CROs through critical, time-sensitive decision-making to achieve regulatory goals
    • Coordinate a cohesive program, interpreting all findings against the same standards and principles to discern the data throughline
    • Structure multi-year scientific programs to support clinical timelines
  • Submissions & Representation

    Contextualize scientific findings in integrated toxicology assessments for Regulatory submissions to the US FDA, Health Canada, and the EMA

    • Compose nonclinical sections of IND/CTA/IMPDs, NDA/NDS/MAAs, IBs, CAC communications, safety informational amendments, waiver requests, meeting requests, briefing books, and package inserts
    • Define margins of safety to enable risk/benefit analysis

    Position Nonclinical in meetings with Regulatory Agencies

    • Achieve pre-IND/CTA, EOP2, pre-NDA/NDS, and Type A and C Guidance meeting goals
  • Due Diligence

    Conduct nonclinical due diligence for product acquisitions

    • Identify program gaps
    • Project budgets and timelines for advancement

Contact Tox Clarity to Get Started